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Study of three types of treatment for leg ulcers of people with problems arising from leprosy

Zinc oxide versus hydrogel ointment in the treatment of chronic ulcer in people with leprosy sequelae: a pilot randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7rh8y2
Enrollment
Unknown
Registered
2018-06-02
Start date
2017-09-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leprosy

Interventions

Sample will consist of 15 patients who have had leprosy and have ulcers in the lower limbs
They will be divided into three groups, oriented on how to make the bandages in the residence and will receive the product according to randomization: Group 0 (05 patients) use hydrogel, Group 1 (05 p
Other
D01.650.550.975

Sponsors

Faculdade de Medicina de Botucatu UNESP
Lead Sponsor
Instituto Lauro de Souza Lima
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Have treatment completed for leprosy confirmed in the medical record by ICD A30; have leg ulcer; both genres; Age between 18 and 90 years

Exclusion criteria

Exclusion criteria: Use of systemic antimicrobials; infected or critically colonized ulcers that present evidence of an infectious process.

Design outcomes

Primary

MeasureTime frame
Recruitment rate in the study for six months, calculated by the number of participants included in the study divided by the total number of eligible patients X 100.;Participants' adherence rate to the proposed treatment, calculated by the number of participants using the indicated product divided by the number of participants included X 100 and the rate of return to the assessments, calculated by the number of participants attending for reevaluation divided by the total number of participants included X 100.

Secondary

MeasureTime frame
Efficacy of interventions in the three study groups: Hydrogel, zinc oxide 20% and zinc oxide 25%, obtained by comparing the median PUSH and Pain Scale scores obtained in the baseline evaluation with those obtained in the octave week post-treatment.

Countries

Brazil

Contacts

Public ContactRegina Bernardo

Instituto Lauro de Souza Lima

regis.maldonado@hotmail.com55 14 3103 5900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)